ANDA 211925

MICRO LABS

FDA Drug Application

Application #211925

Application Sponsors

ANDA 211925

MICRO LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 12.5MG BASE;5MG	0	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
002	TABLET;ORAL	EQ 25MG BASE;10MG	0	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211925
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE","strength":"EQ 12.5MG BASE;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE","strength":"EQ 25MG BASE;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)